EP3355904A4 - IDENTIFICATION OF EFFECTIVE DOSE SHEETS FOR TISSUE-SPECIFIC ALKALINE PHOSPHATASE ENZYMERSAT THERAPY OF HYPOPHOSPHATASIA - Google Patents

IDENTIFICATION OF EFFECTIVE DOSE SHEETS FOR TISSUE-SPECIFIC ALKALINE PHOSPHATASE ENZYMERSAT THERAPY OF HYPOPHOSPHATASIA Download PDF

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Publication number
EP3355904A4
EP3355904A4 EP16852428.8A EP16852428A EP3355904A4 EP 3355904 A4 EP3355904 A4 EP 3355904A4 EP 16852428 A EP16852428 A EP 16852428A EP 3355904 A4 EP3355904 A4 EP 3355904A4
Authority
EP
European Patent Office
Prior art keywords
hypophosphatase
posological
tnsalp
regimes
therapy
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP16852428.8A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP3355904A1 (en
Inventor
Rajendra Pradhan
Xiang Gao
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Alexion Pharmaceuticals Inc
Original Assignee
Alexion Pharmaceuticals Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Alexion Pharmaceuticals Inc filed Critical Alexion Pharmaceuticals Inc
Publication of EP3355904A1 publication Critical patent/EP3355904A1/en
Publication of EP3355904A4 publication Critical patent/EP3355904A4/en
Pending legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/465—Hydrolases (3) acting on ester bonds (3.1), e.g. lipases, ribonucleases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/34—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving hydrolase
    • C12Q1/42—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving hydrolase involving phosphatase
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y301/00—Hydrolases acting on ester bonds (3.1)
    • C12Y301/03—Phosphoric monoester hydrolases (3.1.3)
    • C12Y301/03001—Alkaline phosphatase (3.1.3.1)
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/84—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving inorganic compounds or pH
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/10—Musculoskeletal or connective tissue disorders
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/52—Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Epidemiology (AREA)
  • Hematology (AREA)
  • Genetics & Genomics (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Molecular Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • General Engineering & Computer Science (AREA)
  • Rheumatology (AREA)
  • Obesity (AREA)
  • Diabetes (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Dermatology (AREA)
  • Biomedical Technology (AREA)
  • Microbiology (AREA)
  • Biophysics (AREA)
  • Urology & Nephrology (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Biotechnology (AREA)
  • Cell Biology (AREA)
EP16852428.8A 2015-09-28 2016-09-27 IDENTIFICATION OF EFFECTIVE DOSE SHEETS FOR TISSUE-SPECIFIC ALKALINE PHOSPHATASE ENZYMERSAT THERAPY OF HYPOPHOSPHATASIA Pending EP3355904A4 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562234025P 2015-09-28 2015-09-28
US201562238015P 2015-10-06 2015-10-06
PCT/US2016/054013 WO2017058822A1 (en) 2015-09-28 2016-09-27 Identifying effective dosage regimens for tissue non-specific alkaline phosphatase (tnsalp)-enzyme replacement therapy of hypophosphatasia

Publications (2)

Publication Number Publication Date
EP3355904A1 EP3355904A1 (en) 2018-08-08
EP3355904A4 true EP3355904A4 (en) 2019-06-12

Family

ID=58424685

Family Applications (1)

Application Number Title Priority Date Filing Date
EP16852428.8A Pending EP3355904A4 (en) 2015-09-28 2016-09-27 IDENTIFICATION OF EFFECTIVE DOSE SHEETS FOR TISSUE-SPECIFIC ALKALINE PHOSPHATASE ENZYMERSAT THERAPY OF HYPOPHOSPHATASIA

Country Status (4)

Country Link
US (1) US11229686B2 (cg-RX-API-DMAC7.html)
EP (1) EP3355904A4 (cg-RX-API-DMAC7.html)
JP (1) JP6868617B2 (cg-RX-API-DMAC7.html)
WO (1) WO2017058822A1 (cg-RX-API-DMAC7.html)

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EP3404102B1 (en) 2004-04-21 2021-08-11 Alexion Pharmaceuticals, Inc. Bone delivery conjugates and method of using same to target proteins to bone
US10822596B2 (en) 2014-07-11 2020-11-03 Alexion Pharmaceuticals, Inc. Compositions and methods for treating craniosynostosis
EP3226891B1 (en) 2014-12-05 2025-06-25 Alexion Pharmaceuticals, Inc. Treating seizure with recombinant alkaline phosphatase
JP6868561B2 (ja) 2015-01-28 2021-05-12 アレクシオン ファーマシューティカルズ， インコーポレイテッド アルカリホスファターゼ欠損を有する被験者を治療する方法
HK1257341A1 (zh) 2015-08-17 2019-10-18 Alexion Pharmaceuticals, Inc. 硷性磷酸酯的制造
US11229686B2 (en) 2015-09-28 2022-01-25 Alexion Pharmaceuticals, Inc. Reduced frequency dosage regimens for tissue non-specific alkaline phosphatase (TNSALP)-enzyme replacement therapy of hypophosphatasia
US11400140B2 (en) 2015-10-30 2022-08-02 Alexion Pharmaceuticals, Inc. Methods for treating craniosynostosis in a patient
EP3426286A4 (en) 2016-03-08 2019-12-04 Alexion Pharmaceuticals, Inc. PROCESS FOR TREATING HYPOPHOSPHATASIA IN CHILDREN
CN109152820A (zh) 2016-04-01 2019-01-04 阿雷克森制药公司 用碱性磷酸酶治疗肌肉无力
WO2017173395A1 (en) 2016-04-01 2017-10-05 Alexion Pharmaceuticals, Inc. Methods for treating hypophosphatasia in adolescents and adults
US10988744B2 (en) 2016-06-06 2021-04-27 Alexion Pharmaceuticals, Inc. Method of producing alkaline phosphatase
EP3500289B1 (en) 2016-08-18 2024-10-09 Alexion Pharmaceuticals, Inc. Asfotase alfa for use in treating tracheobronchomalacia
CA3057502A1 (en) 2017-03-31 2018-10-04 Alexion Pharmaceuticals, Inc. Methods for treating hypophosphatasia (hpp) in adults and adolescents
WO2018191254A1 (en) * 2017-04-13 2018-10-18 Alexion Pharmaceuticals, Inc. Methods for identifying the health state of hypophosphatasia (hpp) patients
EP3737750B1 (en) 2018-01-09 2024-06-05 Theriva Biologics, Inc. Alkaline phosphatase agents for treatment of neurodevelopmental disorders
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US11913039B2 (en) 2018-03-30 2024-02-27 Alexion Pharmaceuticals, Inc. Method for producing recombinant alkaline phosphatase
US12268733B2 (en) 2018-08-10 2025-04-08 Alexion Pharmaceuticals, Inc. Methods of treating neurofibromatosis type 1 and related conditions with alkaline phosphatase
CN113993541A (zh) 2019-05-06 2022-01-28 合成生物制品有限公司 基于碱性磷酸酶的肿瘤学治疗
JP7268148B2 (ja) * 2019-05-30 2023-05-02 富士フイルム富山化学株式会社 医療情報登録支援装置、医療情報登録支援装置の作動方法、及びプログラム
AU2020398898A1 (en) 2019-12-09 2022-07-21 Alexion Pharmaceuticals, Inc. Alkaline phosphatase polypeptides and methods of use thereof
EP4084819A1 (en) 2020-01-03 2022-11-09 The United States of America, as represented by the Secretary, Department of Health and Human Services Tnap locally administered for promoting periodontal health
CN113496072B (zh) * 2020-03-22 2024-07-02 杭州环特生物科技股份有限公司 用于安全性评价的斑马鱼转换人用剂量的换算方法
CN117042791A (zh) 2021-02-12 2023-11-10 阿雷克森制药公司 碱性磷酸酶多肽及其使用方法
WO2024163665A1 (en) * 2023-01-31 2024-08-08 Unlearn.AI, Inc. Systems and methods for prognostic covariate adjustment in logistic regression for randomized controlled trial design

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